News & Analysis as of

Manufacturers Compliance European Union

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

White & Case LLP on

Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Davis Wright Tremaine LLP

European Accessibility Act Goes Live

As of June 28, 2025, enforcement of the European Accessibility Act (EAA or the Act) can officially begin, marking a significant milestone for digital accessibility in the European Union (EU). The EAA establishes comprehensive...more

Hogan Lovells

The path to circularity - Navigating through the EU’s sustainable product regulations on batteries, deforestation, ecodesign,...

Hogan Lovells on

The European Commission's new efforts to boost the EU's competitiveness through the Clean Industrial Deal and sweeping regulatory simplification have garnered significant attention. At the same time, circularity remains a...more

King & Spalding

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

King & Spalding on

Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Amundsen Davis LLC

Minimizing Product Liability Risks Caused by AI: Practical Tips for Businesses

Amundsen Davis LLC on

The use of artificial intelligence AI (AI) touches many sectors in the United States, and the business world is no exception. While this exciting development has proven useful for many businesses, it is also a new source of...more

Alston & Bird

D-Day for the EU Cyber Resilience Act

Alston & Bird on

Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more

BCLP

Key Insights on the EU Cyber Resilience Act - What Businesses Need to Know

BCLP on

The Cyber Resilience Act (CRA) is a groundbreaking piece of legislation designed to enhance the cybersecurity of digital products and services made available in the EU. Published last week in the Official Journal of the...more

Goodwin

The NIS 2 Era Is Here: Are You Compliance-Ready?

Goodwin on

With the deadline for Member States to transpose the European Union’s updated Network and Information Systems Directive (Directive (EU) 2022/2555) (NIS 2 or Directive) into national law, with the Directive having passed on 18...more

Goodwin

EU Adopts Cyber Resilience Act for Connected Devices

Goodwin on

On October 10, 2024, the European Council officially adopted the Cyber Resilience Act (CRA), a regulation designed to ensure that products with digital features are secure to use and resilient against cyber threats, and that...more

DLA Piper

Data Act Frequently Asked Questions Answered by the EU Commission

DLA Piper on

The EU Data Act is one of the cornerstones of the EU's Data Strategy and introduces a new and horizontal set of rules on data access and use to boost the EU's data economy. Most of the provisions of the Data Act will become...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s AI Act: A Review of the World’s First Comprehensive Law on Artificial Intelligence and What This Means for EU and Non-EU...

The agreed text of the AI Act was published on July 12, 2024, essentially starting the clock on the legal deadlines contained in it. Its obligations will apply in tiered phases, with the first key obligations being enforced...more

Pillsbury - PFAS Observer

French Parliament Unanimously Approves a Bill Banning Certain PFAS Products

As regulation of the use of PFAS in consumer products continues to develop at a rapid pace in the United States, businesses that manufacture or sell products internationally should also keep their fingers on the pulse of...more

Pillsbury - Internet & Social Media Law Blog

The EU and UK Introduce New IoT Security Standards

The FCC’s recent introduction of a new Voluntary Cybersecurity Labelling Program for consumer Internet of Things (IoT) products reflects the continued desire by U.S. regulators to bolster the security of the ever-increasing...more

Baker Donelson

Who's Who under the EU AI Act: Spotlight on Key Actors

Baker Donelson on

Who will play the leading role if we make a new series about AI? If you interview Steven Spielberg, Sundar Pichai, and Sam Altman, you might receive three distinct ideas ranging from the 2001 classic "AI: Artificial...more

K&L Gates LLP

Brussels Regulatory Brief: February 2024

K&L Gates LLP on

Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...more

Venable LLP

Preparing for the EU Cyber Resilience Act

Venable LLP on

The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Foley & Lardner LLP

What Every Multinational Company Should Know About . . . Supply Chain Integrity

Foley & Lardner LLP on

Both enforcement agencies and consumers increasingly are focused on manufacturers’ supply chains. Human rights enforcement frameworks increasingly have real teeth. Both the United States and the European Union either have, or...more

Foley & Lardner LLP

Keeping the “S” in ESG: Human Rights & Supply Chain

Foley & Lardner LLP on

Companies in the manufacturing industry must continue to keep a close eye on the “S” in ESG. One key aspect of the “social” component of ESG involves respecting human rights in supply chains. Indeed, manufacturers are facing...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

McDermott Will & Schulte

UK REACH Update: Imminent Deadlines and Challenges

McDermott Will & Schulte on

While it is nearly a year into the post-Brexit chemicals regulatory regime, the infrastructure to accommodate UK REACH registrations is not yet running smoothly and as a result importers and distributors of chemical...more

Society of Corporate Compliance and Ethics...

European Commission releases report calling for 'right to repair'

CEP Magazine (May 2002) The European Commission released a plan on March 11, the Circular Economy Action Plan,  that builds on the Ecodesign Directive that will help guide European Union-wide economic policy toward 2050....more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

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